It's valid to want to automate inefficient systems, and more than that, it's actually imperative. The companies that master the regulatory and technical challenges of hands-free validation today will steer their way clear to competitive advantage tomorrow.

Heading toward hands-free validation

Posted on Posted in Electronic QMS, JIRA, Validation microsite

Over the course of working with dozens of innovative, exceptional companies, I’m always struck by their commonalities of purpose and process. While they all are creating products poised to help us all live happier, healthier and more productive lives, ironically enough many tend to put themselves through sadly torturous, inefficient circumstances before their products can see the light of day.

And more often then not, the validation cycle is the place where all hell breaks loose.

Case in point:

One of the biggest and most innovative pharma companies in the world hired us to set up a Jira Service Desk for them.

The contract was signed in late June.

By mid September, the Jira Service Desk installation on their development environment and configuration were all completed.

This left validation… which took a jaw-dropping six months in order to finally make it into production.

This means:

It took just 12 weeks to gather requirements, iterate through several versions of configurations, and complete vetting technical issues and specification freeze. The technical specifications and manual test scripts were also finished during that period.
It took more than double that amount of time – 30 weeks — for validation, qualification and installation to production.
These numbers are more staggering when you realise that almost all of the delay was due to paperwork: manual adjustments, formal review and approval processes. The actual technical defects or infrastructure issues we faced were very limited, and all were resolved swiftly.

The lesson from this particular situation is clear – for those companies reliant on lengthy, paper-driven validation processes, innovation is slowed to snail’s pace. By the time it gets to make an impact, it is, well, old news.

Clearly, the industry is in transition. New organisations in particular are refusing to align themselves with archaic practices. It has already become mainstream to create all the design elements within tools, which automatically generate traceability matrices. In the near future, these tools will have to up their game and produce all the validation records (i.e. requirements specifications, test scripts, etc.) simultaneously as part of the Continuous Integration cycle.

Automation will not stop there, but instead will cover the complete spectrum of validation and qualification activities. Manual test scripts will be replaced with complete automation of the test cycle. Installation will be automatic and include qualifications tests.

Recently I met a startup that has the bold vision to deliver the first version of their product using a completely hands-free validation, installation and qualification cycle. Their current technical challenge is that their automatic cycle is using 64 servers and takes too long. Their tests cycle takes 24 hours.

Should I have told them that in some places validation takes as much as 30 weeks?

As it stands, the regulatory challenge they will be facing might be much larger then their technological one. Will inspectors know how to assess their hands-free approach?

While the answer to that is unclear in today’s transitional world, what is clear is that is where we are heading. It’s valid to want to automate inefficient systems, and more than that, it’s actually imperative. The companies that master the regulatory and technical challenges of hands-free validation today will steer their way clear to competitive advantage tomorrow.